Effects of Insulin Detemir and NPH Insulin on Renal Handling of Sodium, Fluid Retention, and Weight in Type 2 Diabetic Patients (Le-Na)

This study has been completed.
Sponsor:
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00742976
First received: August 27, 2008
Last updated: January 19, 2010
Last verified: June 2008
  Purpose

Hypothesis: Changing type 2 patients treatment from Insulin Insulatard to Insulin Detemir will increase their excretion of sodium in the urine and thereby decrease their extracellular volume and body weight. 24 patients are divided into 2 groups and their insulin treatment is shifted while their body composition, sodium excretion, weight and extracellular volume is monitored.


Condition Intervention Phase
Diabetes Type 2
Weight Gain
Drug: Insulin Detemir; Insulin Insulatard
Drug: Insulin Detemir, Insulin Insulatard
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Effects of Insulin Detemir and NPH Insulin on Renal Handling of Sodium, Fluid Retention and Weight in Type 2 Diabetic Patients

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • change in weight; change in extracellular volume [ Time Frame: 17 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • sodium excretion in urine, 24 hour blood pressure, body composition change,urine osmolality, urine albumin excretion, GFR, HbA1c, Blood lipid profile, NT-proBNP, plasma Albumin, Plasma metanephrines, aldosterone, active renin, angiotensin II [ Time Frame: 17 weeks ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: June 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
8 weeks of insulin Detemir, then cross over to 8 Weeks of Insulatard, then cross over to 1 week of Detemir
Drug: Insulin Detemir, Insulin Insulatard
Fixed doses in study period (if possible). Insulin Detemir once daily, Insulin Insulatard twice daily.
Active Comparator: 2
8 weeks of Insulin Insulatard, then cross over to 8 weeks of insulin Detemir, then crossover to 1 week of Insulin Insulatard
Drug: Insulin Detemir; Insulin Insulatard
Dosage is individual but fixed in study period (if possible). Detemir is given once daily, Insulatard is given twice daily.
Drug: Insulin Detemir, Insulin Insulatard
Fixed doses in study period (if possible). Insulin Detemir once daily, Insulin Insulatard twice daily.

Detailed Description:

Type 2 diabetic patients experience weight gain when receiving insulin treatment. There has been reports that the weight gain is less or absent when patients are treated with Insulin Detemir. Patients with diabetes have increased total body sodium and increased extracellular volume. We hypothesize that part of the weight gain seen is due to increase in extracellular volume and that the lesser weight gain seen in patients treated with Detemir is due to an lesser increase in extracellular volume. We believe that the cause of this difference is the different pharmacokinetic properties of insulin Detemir. Insulin Detemir i protein bound and is therefore not excreted in the kidneys. This may cause less sodium reabsorption, than with other insulins, and therefore less increase in extracellular volume.

We test this hypothesis by examining urinary sodium excretion, extracellular volume by GFR measurements, Body composition by DEXA scan, body weight, and 24 hour blood pressure.In patients that are changed from Insulin Insulatard to Insulin Detemir and back.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes according to WHO 1999 criteria for at least 3 month
  • Insulin treated for at least 1 month
  • BMI 25-40
  • Age 18-80
  • Hb1Ac < 10%

Exclusion Criteria:

  • Hypertension not well regulated
  • Serum creatinine > 130 micromol/l
  • Non-diabetic kidney disease
  • Disease that may cause invalid hgbA1c measurement
  • Substance abuse
  • Recent use of Detemir
  • Pregnancy or risk of becoming pregnant
  • Any condition that may disturb protocol adherence (language barrier etc) urinary albumin > 30 mg/24hours ( before screening)
  • Use of drugs that may influence blood glucose (except oral antidiabetics)
  • Use of drugs that may influence sodium balance,i.e diuretics ( tiazides accepted)
  • Clinical significant disease that may influence outcome ( cancer etc)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00742976

Locations
Denmark
Dept of Endocrinology, Rigshospitalet
Copenhagen, København Ø, Denmark, DK_2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Principal Investigator: Tonny Jensen, M.D MSci. Dept of Endocrinology at Rigshospitalet, Copenhagen.
  More Information

No publications provided by Rigshospitalet, Denmark

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tonny Jensen, Dept. of Endocrinology; Rigshospitalet.
ClinicalTrials.gov Identifier: NCT00742976     History of Changes
Other Study ID Numbers: EudraCT 2008-001602-16
Study First Received: August 27, 2008
Last Updated: January 19, 2010
Health Authority: Denmark: Danish Medicines Agency
Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by Rigshospitalet, Denmark:
Weight gain in insulin treated type 2 diabetes
extracellular volume
insulin treatment
sodium retention

Additional relevant MeSH terms:
Body Weight
Weight Gain
Diabetes Mellitus, Type 2
Signs and Symptoms
Body Weight Changes
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Isophane insulin, beef
Insulin
Insulin, Long-Acting
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014